- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01147354
Effect of Selenium Supplementation on Inflammatory,Oxidative and Nutritional Markers in Hemodialysis Patients
31. januar 2012 opdateret af: Zahra Sohrabi
The aim of this study is to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
After screening all of 280 patients under regular HD in Faghihi Hospital Hemodialysis Center, 80 stable patients in the age range of 18-80 years old were found to be eligible for enrollment and gave their informed consent to participate in this trial.
Subjects were excluded if they were prescribed any multivitamins or immunosuppressive drugs or taking antioxidant supplements including vitamin E, vitamin C, lipoic acid, omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study or if they had been hospitalized in the previous month, we also excluded the ones who were pregnant or had active infections.
The Ethics Committee of Shiraz University of Medical Sciences reviewed and approved the protocol of this study.These patients were randomly assigned in a 1:1 ratio into 2 groups of selenium(200µg) or placebo and were followed for 12 weeks.In order to determine the nutritional statuses of all patients, at the baseline, the questions of SGA and MIS questionnaire were read to the patients and completed in person by the main investigator.
The questions of SGA and MIS were also asked by the same person at the end of treatment phase.Before the onset of the treatment and after the end of the treatment phase of the study, 10cc blood samples were taken from each patient.The blood was taken from the patient's arm used for hemodialysis cannula just before the beginning of the hemodialysis procedure.
The serum was separated by centrifugation at 3000 g/min for 5 min and stored at -70°C.
Serum levels of malondialdehyde (MDA), interleukin-6 (IL-6), high sensitive C-reactive protein (HSCRP), ferritin, transferrin, homocysteine, calcium , phosphate, parathyroid hormone (PTH), albumin, blood urea nitrogen (BUN), and creatinine as well as hemoglobin (Hb) levels were measured in all patients at the baseline and at the end of treatment phase of study.The aim of this study was to evaluate the effect of selenium supplementation on oxidative, inflammatory and nutritional markers in hemodialysis patients.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
80
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Fars
-
Shiraz, Fars, Iran, Islamisk Republik
- Shiraz University of Medical Sciences
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients who were dialyzed three times a week at least for 3 months or more
Exclusion Criteria:
- Patients who took any multivitamins or immunosuppressive drugs within 2 months prior to enrollment in the study
- Patients consuming antioxidant supplements including vitamin E, vitamin C, lipoic acid,omega-3 fatty acids, soy extracts and green-tea preparations within 2 months prior to enrollment in the study
- Patients who were Hospitalized in the previous month
- Patients who had active infections
- Being pregnant
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: experimental group
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
|
The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
|
|
Placebo komparator: control group
The patients in this arm took one placebo capsule daily for 12 weeks.
|
The patients in this arm took one placebo capsule daily for 12 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective Global Assessment
Tidsramme: 12-weeks
|
changes in nutritional status according to SGA from baseline to end of treatment
|
12-weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
serum albumin
Tidsramme: 12-weeks
|
12-weeks
|
|
hemoglobin
Tidsramme: 12-weeks
|
12-weeks
|
|
serum malondialdehyde
Tidsramme: 12-weeks
|
12-weeks
|
|
serum parathyroid hormone
Tidsramme: 12-weeks
|
12-weeks
|
|
serum interleukin-6
Tidsramme: 12-weeks
|
12-weeks
|
|
serum phosphorus
Tidsramme: 12-weeks
|
12-weeks
|
|
serum high sensitive c-reactive protein
Tidsramme: 12-weeks
|
12-weeks
|
|
serum calcium
Tidsramme: 12-weeks
|
12-weeks
|
|
serum lipoproteins
Tidsramme: 12-weeks
|
12-weeks
|
|
serum ferritin
Tidsramme: 12-weeks
|
12-weeks
|
|
serum homocysteine
Tidsramme: 12-weeks
|
12-weeks
|
|
total iron binding capacity (TIBC)
Tidsramme: 12-weeks
|
12-weeks
|
|
body mass index (BMI)
Tidsramme: 12-weeks
|
12-weeks
|
|
malnutrition-inflammation score (MIS)
Tidsramme: 12-weeks
|
12-weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studiestol: Mohammad mahdi Sagheb, M.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Zahra Sohrabi, Ph.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Moosa Salehi, Ph.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Maryam Ekramzadeh, Ph.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Mohammad Kazem Fallahzadeh, M.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Maryam Ayatollahi, Ph.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Bita Geramizadeh, M.D, Shiraz University of Medical Sciences
- Ledende efterforsker: Jafar Hassanzadeh, Ph.D, Shiraz University of Medical Sciences
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2009
Primær færdiggørelse (Faktiske)
1. juli 2009
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
17. juni 2010
Først indsendt, der opfyldte QC-kriterier
17. juni 2010
Først opslået (Skøn)
22. juni 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
2. februar 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. januar 2012
Sidst verificeret
1. januar 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 88-4747
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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